5 Chinese firms approved to make Merck’s COVID pills for poor countries: agency

Zhuang Pinghui, South China Morning Post

Posted at Jan 22 2022 11:17 AM

Several Chinese companies are now allowed to make cheap versions of Merck’s Covid-19 pills to supply low-income countries, a UN-backed organisation said on Thursday.

Shanghai Fosun Pharmaceutical, BrightGene Bio-Medical Technology, Shanghai Desano Pharmaceuticals and Lonzeal Pharmaceuticals have permission to produce both the raw ingredients and finished product of the oral antiviral medicine molnupiravir, the Medicines Patent Pool (MPP) said on Thursday.
Langhua Pharmaceutical is permitted to make only the raw ingredients, according to the MPP, a United Nations-backed organisation working to expand access to life-saving medicines for low- and middle-income countries.

They are among 27 companies from 11 countries, including Bangladesh’s Beximco Pharmaceuticals, India’s Natco Pharma and South Africa’s Aspen Pharmacare, that were also granted the non-exclusive licences to produce the raw ingredients for molnupiravir, the finished drug or both.

“We are encouraged by the large number of new and existing partners that have moved quickly to secure a sub-licence for molnupiravir through the MPP,” MPP executive director Charles Gore said.

“This is a critical step towards ensuring global access to an urgently needed Covid-19 treatment and we are confident that, as manufacturers are working closely with regulatory authorities, the anticipated treatments will be rapidly available in [low- and middle-income countries].”

But China is not among the 105 low and middle-income countries that will be supplied with the generic drugs.

Molnupiravir is an antiviral drug that decreases the ability of a virus to replicate, slowing the disease. It needs to be given twice a day for five days at an early stage of disease to be effective. The drug initially showed a roughly halving in the risk of hospitalisation and death. But complete data released in November showed that the fall was about 30 per cent.

It was initially developed by Emory University and then pursued further by Merck and Ridgeback Biotherapeutics.

The drug has been authorised for use in more than 10 countries, including in the United States, Britain and Japan. It is under assessment by the World Health Organization.

In October, Merck and Ridgeback Biotherapeutics also reached an agreement with the MPP to allow the agency to further license non-exclusive sublicences to manufacturers to supply molnupiravir to 105 low- and middle-income countries.

The requests for sublicences from generic producers were reviewed solely by the MPP and presented to Merck, the agency said.

None of the developers will receive royalties from sales of molnupiravir from the MPP sublicensed manufacturers as long as Covid-19 remains classified as a public health emergency of international concern by the WHO.

Previously, Merck has signed a long-term supply agreement with Unicef to supply up to 3 million courses of molnupiravir throughout the first half of 2022 for distribution in more than 100 low- and middle-income countries following regulatory authorisations.

Pfizer also entered into a voluntary licensing pact with the MPP in November that allows the organisation to grant sublicences to qualified generic medicine manufacturers to make the antiviral pill nirmatrelvir for 95 low- and middle-income countries, which together account for more than half of the world’s population.

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